Study of Hepatitis C Virus (HCV) Entry Inhibitor in Liver Transplant Recipients With HCV Infection

Sponsor

Schiano, Thomas D., MD (Other)

Overall Status

Terminated

CT.gov ID

NCT01560468

Collaborator

iTherX Pharmaceuticals Inc. (Industry)

Enrollment

Location

Arm

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will test the safety and tolerability of HCV Entry Inhibitor ITX 5061 in Liver Transplant Recipients with Hepatitis C infection. The investigators hypothesize that ITX 5061 oral monotherapy will be safe in adults during and after liver transplantation and that therapy will also inhibit HCV infection of newly transplanted livers in adults with prior HCV infection.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Infection	Drug: ITX 5061	Phase 1

Detailed Description

All subjects will receive 28 days of ITX 5061 beginning at the time of transplant.

Dosing of ITX 5061 is as follows:

Day of Transplant prior to surgery: ITX 5061 300 mg Day of Transplant following surgery: ITX 5061 300 mg Post-Operative Days 1-6: ITX 5061 300 mg Post-Operative Days 7-27: ITX 5061 150 mg

Subjects will be monitored for HCV RNA levels, HDL cholesterol and ITX 5061 drug concentration levels.

A liver biopsy will be performed at 6 months post-transplant to assess for histological signs of HCV recurrence.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Phase I Study of Hepatitis C Virus (HCV) Entry Inhibitor (ITX 5061) in Liver Transplant Recipients With HCV Infection

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Apr 1, 2018

Actual Study Completion Date :

Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ITX 5061 Subjects will receive ITX 5061 for 28 days beginning at the time of liver transplantation for hepatitis C virus. 300mg will be administered on the day of surgery and for one week post transplant, followed by 150mg for an additional 21 days.	Drug: ITX 5061 300 mg given orally beginning at the time of liver transplantation and for 1 week post-transplant followed by 150 mg orally for an additional 21 days.

Arm

Intervention/Treatment

Experimental: ITX 5061

Subjects will receive ITX 5061 for 28 days beginning at the time of liver transplantation for hepatitis C virus. 300mg will be administered on the day of surgery and for one week post transplant, followed by 150mg for an additional 21 days.

Drug: ITX 5061

300 mg given orally beginning at the time of liver transplantation and for 1 week post-transplant followed by 150 mg orally for an additional 21 days.

Outcome Measures

Primary Outcome Measures

Incidence of HCV recurrence post-transplant [28 days]
We hypothesize that ITX 5061 oral monotherapy will be safe in adults during and after liver transplantation and will inhibit HCV infection of newly transplanted livers in adults with prior HCV infection. The number of treated subjects who are infected at 28 days post-transplant will be compared to the historical control rate (95%).

Secondary Outcome Measures

Change in serum HCV RNA [3 months after transplant]
To determine the change in serum HCV RNA from study entry to end of dosing (28 days) and 3 month follow up
Levels of ITX 5061 [28 days]
To assess trough levels of plasma ITX 5061 throughout the dosing period
Viral dynamics of serum HCV RNA [24 hours post-transplant]
To characterize the viral dynamics of serum HCV RNA levels during the first 24 hours post-transplant
Potential changes in plasma HCV E2 [28 days]
To characterize potential changes in plasma HCV E2 (HCV envelope protein) regions in the setting of ITX 5061 administration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 72 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-72
Patients accepted onto waiting list for liver transplantation for HCV related liver disease and receiving a deceased donor liver allograft
HCV RNA (+) at time of listing for transplantation. All HCV genotypes will be eligible
Patients with HCC and those receiving hepatitis B core (+) donor livers will be eligible
Standard immunosuppression protocol with tacrolimus, corticosteroid taper, and mycophenolate mofetil